Evaluation of Cerebral Thrombembolism After TAVR (EARTH - TAVR)

March 31, 2019 updated by: Ulf Landmesser, Charite University, Berlin, Germany
EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Calcific aortic valve stenosis is the most common cause of aortic stenosis (AS) among adults in Europe and in the United States. The prevalence of moderate or severe AS was found to be age-dependent rising from 0.02% in patients aged 18-44 years to 2.8% in patients aged ≥ 75 years. Among patients at prohibitive surgical risk, TAVR has become the treatment of choice.The safety and efficacy of TAVR compared with medical management and SAVR has been demonstrated in clinical trials.The composite of the rate of all-cause death or stroke was 27% and 37% in TAVR patients after 1 and 2 years, respectively.Even though parts of the strokes occur during the peri-procedural period, the patients remain at risk of stroke throughout the first months after the procedure.

EARTH-TAVR is a diagnostic multicenter study performing in association with the GALILEO trial (NCT02556203), which is investigating cerebral embolization with MRI and neurocognitive testing in patients undergoing TAVR, who are treated with anticoagulation (Rivaroxaban/ASS) or DAPT (Clopidogrel/ASS). GALILEO is a global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes.

Investigators aim to investigate peri-interventional and delayed cerebral embolization in the early period (3 months) after TAVR and to analyze associations between neurocognitive parameters and cerebral embolization patterns in patients on different antithrombotic treatment regimes.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin, Campus Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 18 years or older wirth aortic valve stenosis receiving TAVR-Intervention.

Description

Inclusion Criteria:

  • Man or woman of 18 years of age or older
  • Via iliofemoral or subclavian access
  • Provide written IC

Exclusion Criteria:

  • Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant Treatment
  • Any other indication for continued treatment with any oral anticoagulant (OAC)
  • Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
  • Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
  • Clinically overt stroke within the last 3 months
  • Planned coronary or vascular intervention or major surgery
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
  • Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
  • Any contraindication for cerebral MRI, in particular:
  • non-MRI-conditional pacemakers
  • MRI conditional pacemakers <4 weeks after implant
  • any metal fragments in the eye
  • aneurysm clip in the brain
  • severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline
Time Frame: 3 months after TAVR versus baseline

Occurrence and extent of cerebral embolization in patients after TAVR measured by total volume of new ischemic cerebral lesions on DWI and FLAIR MRI.

Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images)
3 months after TAVR versus baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel.
Time Frame: 3 months post TAVR versus baseline
Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the 3 months post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images).
3 months post TAVR versus baseline
extent and location of new cerebral lesions early AFTER TAVR and after 3 months
Time Frame: MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR
To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be compared 3 months post TAVR versus the post-TAVR MRI scan
MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR
Assessment of different neurocognitive tests (NIHSS-score, MOCA-score, MOT-score, PAL-score, RTI-score, SWM-score, AST-score, CAM-Score); change of sum scores before, after and 3 months after TAVR procedure.
Time Frame: Before TAVR, post TAVR and after 3 months
To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans
Before TAVR, post TAVR and after 3 months
Extent and localization of clinically apparent non-cerebral emboli after TAVR
Time Frame: baseline, post TAVR and after 3 months
To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)
baseline, post TAVR and after 3 months
Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.
Time Frame: Baseline versus 3 months following TAVR
Baseline versus 3 months following TAVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer

Investigators

  • Principal Investigator: Ulf Landmesser, Prof. Dr., Charité - Universitätsmedizin Berlin, Department of Cardiology
  • Study Chair: Matthias Endres, Prof. Dr., Charité - Universitätsmedizin Berlin, Department of Neurology
  • Study Chair: Georg M Fröhlich, PD, Charité - Universitätsmedizin Berlin, Department of Cardiology
  • Study Chair: Volkmar Falk, Professor, German Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 31, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EARTH - TAVR 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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